Corona Virus Disease 19 (Covid19)Phase 3NCT04792021

Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients

A Phase 3 study testing N-acetylcysteine in people with Corona Virus Disease 19 (Covid19) and Corona Virus Infection, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
What is being tested?: N-acetylcysteine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 9 Mar 2021to 1 Apr 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged more than 18 years
Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included

Who cannot join

Known allergy or hypersensitivity to NAC
Pregnancy
Critically ill or mechanically ventilated patients

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Al Assema Hospital
Cairo

Other trials in Egypt

About this study

Official title: Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections

The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.

Read the detailed description

This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows:

Markers of inflammation and oxidative stress
Length of hospital stay
Need for ventilation
Mortality rate

Conditions: Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
Being tested: N-acetylcysteine
Keywords: N-acetylcysteine
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-acetylcysteineDrug
Also called Acetylcysteine
Oral formulation: 600 mg sachets of N-acetylcysteine

Study groups in NCT04792021
Study group	Role	What they receive
N-acetylcysteine (NAC)	Active comparator	Patients receiving N-acetylcysteine (NAC) Receives: Drug: N-acetylcysteine
Control	No intervention	Patients not receiving N-acetylcysteine (NAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in TNF alfa level from baseline
The mean change in TNF alfa is used to assess NAC efficacy
Measured: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death

Secondary outcomes (4)

Change in IL-6 level from baseline
The mean change in IL-6 level is used to assess NAC efficacy
Measured: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Change in glutathione peroxidase level from baseline
The mean change in glutathione peroxidase is used to assess NAC efficacy
Measured: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Length of hospital stay
Duration of hospital stay for admitted patients
Measured: Through study completion ( average 9 months)
Need for mechanical ventilation
Whether a patient required mechanical ventilation (intubation) or not
Measured: Through study completion ( average 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20211 Apr 2022

First posted10 Mar 2021
Study start9 Mar 2021
Primary completion13 Sep 2021
Study completion1 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Corona Virus Disease 19 (Covid19)Studies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm: those receiving N-acetylcysteine (NAC). One arm is the control group : those not receiving N-acetylcysteine (NAC).
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04792021
Sponsor's protocol ID: N-acetylcysteine in COVID 19
Status last verified: Apr 2022
First submitted: 7 Mar 2021
Last updated: 27 Apr 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
ClinicalTrials.gov ID: NCT04792021
Acronym / sponsor ID: N-acetylcysteine in COVID 19
Conditions: Corona Virus Disease 19 (Covid19), Corona Virus Infection, Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
Keywords: N-acetylcysteine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Collaborators: Misr International University
Study start: 9 Mar 2021 (actual)
Primary completion: 13 Sep 2021 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 10 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.

Detailed description

Markers of inflammation and oxidative stress
Length of hospital stay
Need for ventilation
Mortality rate

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Participants are assigned to one of two groups in parallel for the duration of the study. One arm is the intervention arm: those receiving N-acetylcysteine (NAC). One arm is the control group : those not receiving N-acetylcysteine (NAC).

Arm	Type	Receives
N-acetylcysteine (NAC)	Active comparator	Drug: N-acetylcysteinePatients receiving N-acetylcysteine (NAC)
Control	No intervention	–Patients not receiving N-acetylcysteine (NAC)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults aged more than 18 years
Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included

Key exclusion criteria (3 listed)

Known allergy or hypersensitivity to NAC
Pregnancy
Critically ill or mechanically ventilated patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
N-acetylcysteineAlso: AcetylcysteineOral formulation: 600 mg sachets of N-acetylcysteine	Drug	N-acetylcysteine (NAC)

Primary outcome

Change in TNF alfa level from baseline
Time frame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
The mean change in TNF alfa is used to assess NAC efficacy

4 secondary outcomes

Change in IL-6 level from baseline
Time frame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Change in glutathione peroxidase level from baseline
Time frame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Length of hospital stay
Time frame: Through study completion ( average 9 months)
Need for mechanical ventilation
Time frame: Through study completion ( average 9 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sara M. Sherkawy, B.S.P principal investigator

Misr International University

Lamia El Wakeel, Professor study chair

Ain Shams University

Mona Schaalan, Professor study director

Misr International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing N-acetylcysteine in people with Corona Virus Disease 19 (Covid19) and Corona Virus Infection, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in TNF alfa level from baseline (time frame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.